Approval of Import and Export Special Articles for Verification of Health and Quarantine


1. Project name
Approval of Import and Export Special Articles for Verification of Health and Quarantine
2. Scope of Licensing
(1) Blood and blood products
Blood and blood products refer to whole blood, plasma, serum, blood cell, globulin, albumin, fibrinogen, factor preparation, etc.
(2) Human Tissue
The human tissue refers to human organ, tissue, cell, live human embryo cell, human specimen, human secretion, excrement, attachment, and various products processed with human tissue as materials.
(3) Microorganism
The microorganism includes the bacterial or viral strains of medical microorganism such as virus, bacteria, fungi, actinomycetes, rickettsia, spirochetes, chlamydiae and mycoplasmas, as well as the bacterial strains of antibiotics for medical purpose.
 (4) Bio-products
The products for prevention, treatment and diagnosis of human diseases which are prepared by the biological materials such as microorganism, cell and various tissues and fluids of animal and human origin as obtained by applying ordinary technology or the bio-technology such as genetic engineering, cell engineering, protein engineering and fermentation engineering. The said products cover vaccine (including toxoid), antitoxin, cell factor, in-vivo and in-vitro diagnostic products and other active preparations (including toxin, antigen, allergen, mono-clonal antibody, recombinant DNA products, antigen-antibody complex, immune modulator, microbiological preparation, nucleic acid preparation, etc.).
The blood products or bio-products for self-use are not included in the scope of licensing, and the quantity allowed to carry is limited to one period of treatment according to the prescription or product instruction.
3. Licensing Conditions
 (1) For the exit human tissues and blood associated with human genetic resources, the exit certificate issued by China Human Genetic Resources Administrative Office shall be presented in both original and duplicate.
 (2) For the big sample involving over 100 person-portions for medical research or treatment purpose, or the sample that contains or may contain class III-IV pathogenic microorganisms, the entry and exit certificate issued by the Ministry of Health shall be obtained; For the small sample involving less than 100 person-portions (including 100 portions) for medical research or treatment purpose, or the sample that contains or may contain class I-II pathogenic microorganisms, the entry and exit certificate issued by the Health Administrative Department at the level of province, autonomous region or municipality shall be obtained.
 (3) For the entry and exit environmental microorganisms, the safety assessment report on the microorganism issued by the environmental protection department shall be provided.
 (4) For the entry biological products and blood products (being restricted to those for the purpose of treatment, prevention and diagnosis), the “Approval Document for the Import of Biological Products” or the “Approval Document for the Import of Medical Instruments” (being restricted to the diagnostic reagents affiliated to the instruments) issued by the state drug supervision department shall be provided.
 (5) For the exit biological products and blood products (being restricted to those for the purpose of treatment, prevention and diagnosis), the “Drug Sales Certificate” issued by the state drug supervision department and the GMP certificate shall be provided.
4. Implementation body:
Division for Supervision on Health, Shanghai Entry-Exit Inspection and Quarantine Bureau
5. Approval Procedures
 (1)  Application and Acceptance
a. The applicant shall, within 10 days before the goods arrive at the port, apply to the approval authority, fill in the Application Form for Approval of Entry-Exit Special Articles (hereinafter referred to as the Application Form), and provide the relevant materials.
b. The acceptance body shall decide on site whether to accept the application or not, and give written notice at one time if additional materials are required.
c. The approval authority shall decide whether to approve the application or not within 10 working days after the application is accepted, and issue the “Approval Sheet for Entry-Exit Special Articles” (hereinafter referred to “Approval Sheet”), if the application is approved; otherwise, the approval authority shall issue the “Notification of Disapproval”, and state the reasons for the disproval. The applicant may, on the strength of the “Approval Sheet”, go through the other inspection and quarantine formalities with the branch office at the port of entry for entry special articles, or with the local branch office for exit special articles.
d. If necessary, the approval authority may organize experts to carry out risk assessment on the entry and exit special articles applying for approval. The applicant has the obligation to provide relevant materials and samples to be tested, and to facilitate the on-site assessment. The time for risk assessment is not included in the working days for approval.
6. Attachments
The applicant shall provide the following materials when filing the application:
 (1) Application Form and attached forms;
 (2) Import/export contract, invoice, and packing list;
 (3) Product name, basic ingredients and source of ingredients, usage, client, products having or likely to have infectivity, contamination and radioactivity, and other matters requiring attention during inspection; the scientific name, generic name and biological characteristics of microorganism, if any;
 (4) For the exit human tissues and blood associated with human genetic resources, the exit certificate issued by China Human Genetic Resources Administrative Office shall be presented in both original and duplicate;
 (5) For the big sample involving over 100 person-portions for medical research or treatment purpose, or the sample that contains or may contain class III-IV pathogenic microorganisms, the entry and exit certificate issued by the Ministry of Health shall be obtained; For the small sample involving less than 100 person-portions (including 100 portions) for medical research or treatment purpose, or the sample that contains or may contain class I-II pathogenic microorganisms, the entry and exit certificate issued by the Health Administrative Department at the level of province, autonomous region or municipality shall be obtained;
 (6) For the entry and exit environmental microorganisms, the safety assessment report on the microorganism issued by the environmental protection department shall be provided;
 (7) For the entry biological products and blood products (being restricted to those for the purpose of treatment, prevention and diagnosis), the “Approval Document for the Import of Biological Products” or the “Approval Document for the Import of Medical Instruments” (being restricted to the diagnostic reagents affiliated to the instruments) issued by the state drug supervision department shall be provided;
 (8) For the exit biological products and blood products (being restricted to those for the purpose of treatment, prevention and diagnosis), the “Drug Sales Certificate” issued by the state drug supervision department and the GMP certificate shall be provided;
 (9) For the organs for transplant, the relevant test report for the donor shall be provided;
 (10) Other materials required by the acceptance body.


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